Fwd: FDA MedWatch - The January 2008 FDA Patient Safety News Is Now Available

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---------- Forwarded message ----------

From: U.S. Food & Drug Administration (FDA) <fda@...>

Date: 8 Jan 2008 13:01

Subject: FDA MedWatch - The January 2008 FDA Patient Safety News Is Now

Available

racemedical@...

[image: MedWatch logo] [image: MedWatch - The FDA Safety Information and

Adverse Event Reporting Program]

FDA Patient Safety News (PSN) is a monthly video news show for healthcare

professionals. It covers significant safety alerts, recalls, new product

approvals, and offers important tips on protecting patients. Read the

complete stories and watch or download the video program at *

http://www.fda.gov/psn* <http://www.fda.gov/psn>. You may have already

received notification of some of these safety issues through the MedWatch

list serve. However, many of these PSN stories contain video footage and

demonstrations that may be especially useful to educators in healthcare

facilities and academic institutions.

Stories in the January 2008 edition include:

*Serious Skin and Hypersensitivity Reactions with Provigil

(modafinil)<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#1>

*

Used to reduce excessive sleepiness in adults with narcolepsy and other

sleep disorders, Provigil can cause life-threatening skin and

hypersensitivity reactions…

*Sudden Hearing Loss from Erectile Dysfunction

Drugs<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#2>

*

Sudden hearing loss reported with PDE5 inhibitors Viagra, Levitra and

Cialis…

*Certain Welch Allyn Defibrillators

Recalled<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#3>

*

Defects in certain AED 10 automatic external defibrillators may cause a

malfunction, and in some cases the device could fail to deliver a shock…

*Marketing of Trasylol (aprotinin)

Suspended<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#4>

*

Preliminary results of a Canadian study indicate that patients may have a

greater risk of death than patients taking either of two other

antifibrinolytic drugs…

*Warning on Fentora Buccal

Tablets<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#5>

*

Life-threatening respiratory depression can occur if fentanyl buccal tablets

are used in patients who are not opioid-tolerant…

*Recall of Thoratec Implantable Ventricular Assist

Devices<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#6>

*

Air leaks may develop in the driveline when the IVAD is used outside the

patient's body…

*Ongoing Safety Review of Maxipime

(cefepime)<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#7>

*

Recent study raises the possibility of an increased risk of death among

patients taking the drug…

*Avoiding Hazards from Using Cleaners and Disinfectants on Electronic

Medical Equipment<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#8>

*

Fires and other damage can occur to wide range of equipment, including

infusion pumps, ventilators, analgesia pumps, computer workstations and

monitoring equipment…

*What to Do about Unretrieved Device

Fragments<http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#9>

*

The fragments may have been left in the body because they could not be

retrieved or because the risk of removing them was greater than the risk of

leaving them in place…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please

send any comments, questions or suggestions about the program to

PSNews@...

**

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Dr.J.Sullivan